Futura Medical Share Discussion Threads

[mdi] 03/5/2024 19:05

How else could the established Voltaren who’s ‘growth rates aren’t necessarily as they were historically’ then be repurposed? With an ‘intent’ where it could or ‘so should be one of those engines that pulls Haleon forward? Don’t Haleon already have all that Voltaren hydroalcoholic vehicle gel production capacity in place? So who wouldn’t he be ‘excited’ at the possibility of packaging and selling a low cost to market similar non medicated hydroalcoholic gel for ED. If indeed market demand actually is sustainable over the next 10 months beyond the initial launch hype.

Note also the careful specific wording ‘should come to the market’

He deliberately refrained from saying it WILL come to the market. Why?




Bruno Monteyne: Hi, good morning, Tobias. As we hear a bit less these days about the Voltaren, then the growth rates aren’t necessarily as they were historically, but together with Haleon, just discussed, it should be one of those engines that pulls Haleon forward. Is there a need for more innovation in Voltaren something like that coming like you’ve done with Sensodyne and new pro variety? Can you comment on that?

on the – erectile dysfunction cream. So we have said at full year that we would intend to launch it in 12 months. So that means now with intent, we’re making good progress on ramping up and building the production. So all these plans are tracking along nicely. And then sort of once we get closer to the launch date, we would, of course, inform you about it. So excited about it. The progress is very much as planned. So next 10 months, this should come to the market then as well.

[petroc] 03/5/2024 18:51

Why would anyone want to launch a similar product to Eroxon? You've spent the last 7 years telling us it doesn't work, so who would seek to emulate a product that has no efficacy? Perhaps you've finally admitted to yourself that Eroxon does what it says on the tin, so you're trying to bash the stock from a different angle.
BTW, we don't really want to hear about your sordid anal intercourse fantasies, so kindly stay on message, instead of constantly trying to muddy the waters with your incessant stock bashing. It's beyond boring.

[mdi] 03/5/2024 18:40

Maybe Haleon have already carried out a blind study proving no evidence of efficacy difference between the two non medicated hydroalcoholic gels? Perhaps Haleon have already submitted a 510k application for their own equivalent Voltaren vehicle gel? Easy to see why Haleon are ‘excited’ that they could have their own placbeo ED gel version on the market in less then six months and leave Futura’s hands tied for another 10 months. If the market for placebo non medicated hydroalcoholic gels like Eroxon is even sustainable for months. Unlikely based on the declining sales seen in UK and Belgium.



‘De Novo authorization will also allow subsequent devices of the same type and intended use to come to the market through the 510k pathway, which could enable the devices to get on the market faster’



the average time to issue a decision in 2021 was 147 days according to FDA data.

For the year up to the end of September 2022, 85 percent of 510(k) applications were issued with a Substantially Equivalent decision from the FDA. A Substantially Equivalent decision means the product has regulatory approval to be sold in the US market.




The vast majority of our FDA 510K clients generally spend in the range of $20,000-$30,000 to have their product or device prepared and reviewed before the actual FDA 510k submission process.

One of the positive sides to seeking a FDA 510K approval for a new medical product, whether tested or untested, is that if there is already a similar FDA approved product being marketed, then the FDA will have to approve any new products that are almost the same as the product that is already FDA 510 K approved and have under gone all required testing, documentation, and registration processes.

So Haleon can if they wish just launch their similar non medicated hydroalcoholic gel based on Voltaren that will ‘meet criteria for same intended use.. Has ˜slightly different technology but produces similar end results’. And is made of similar solvents and also causes evaporative cooling. And is ‘safe and effective’ . Yes. the Voltaren gel technology is already on the market so wont be any issues getting a non medicated form of the voltaren hydroalcoholic gel cleared as just a medical device like Eroxon is.

[mdi] 03/5/2024 17:09

Haleon have indeed ‘tied up’ Futura for another 10 months with this talk ot using their own similar hydroalcoholic evaporative cooling Voltaren vehicle gel also as a comparable innovation in Erectile dysfunction.

So the further delay is that they ‘should’ actually carry out a blind direct efficacy comparison study between their own Voltaren vehicle gel and the Med3000 gel. When no difference then they can demand their upfront payment back and hand back Med3000 to Futura and launch their own non medicated hydroalcoholic gel based on the Voltaren vehicle.



‘When the gel matrix is destroyed after application to the skin, the bound water and alcohol evaporates and a measurable cooling-effect results’

[mdi] 03/5/2024 16:58

Very interesting Beanol

‘the original transaction was not deemed financially significant enough to merit a separate transaction market release. And that remains the the case”

Again the product was only mentioned yesterday due to the same Analyst again bringing up the subject. Also appears to be a veiled warning in yesterdays Q&A which links innovation with Voltaren gel and and the Haleon ‘intent’ on an Erectile dysfunction gel.



Bruno Monteyne: Hi, good morning, Tobias. As we hear a bit less these days about the Voltaren, then the growth rates aren’t necessarily as they were historically, but together with Haleon, just discussed, it should be one of those engines that pulls Haleon forward. Is there a need for more innovation in Voltaren something like that coming like you’ve done with Sensodyne and new pro variety? Can you comment on that?

on the – erectile dysfunction cream. So we have said at full year that we would intend to launch it in 12 months. So that means now with intent, we’re making good progress on ramping up and building the production. So all these plans are tracking along nicely. And then sort of once we get closer to the launch date, we would, of course, inform you about it. So excited about it. The progress is very much as planned. So next 10 months, this should come to the market then as well.

[beanol] 03/5/2024 16:18

I hope you're right J77. I'm an lthThis is the guts of a reply I got a while ago from Haleon to ask why no statements on FUM from Haleon:"As you would expect we have a process to review all news or developments on an ongoing basis to determine what is material for Haleon and what under current regulation and best market practice needs disclosure to the market in the appropriate form. In this instance for the Haleon group, amongst other considerations, the original transaction was not deemed financially significant enough to merit a separate transaction market release. And that remains the the case"

[j777j] 03/5/2024 14:09

Not long before the massive fanfare of the US launch of Eroxon

Fasten seat belts

All eyes on the key US launch Partner Haleon is working towards US launch and whilst visibility on precise launch timings is limited, and is likely to remain so, this is expected to occur before February 2025, but could potentially come earlier. Haleon has committed significant financial resources and we believe is working on numerous pre-launch activities including market research, messaging and building a robust supply chain to ensure a successful roll-out, all of which take time

[blackhorse23] 03/5/2024 10:52

Money moved to APH AlliancePharma [APH] has an impressive record of long-term growth & creating sustainable value for our shareholders & stakeholders-DIVIDEND +5% -PORTFOLIO BROADENED THROUGH ACQUISITION

[mdi] 03/5/2024 10:51

Like the implied claim its ‘clinically proven’ beyond a similar non medicated placebo hydroalcoholic gel in a blind direct efficacy study. Yet the claim cannot be substantiated with evidence from any double blind placebo controlled study?



A. Identifying Claims and Interpreting Ad Meaning

1. Identifying Express and Implied Claims
The first step in evaluating the truthfulness and accuracy of advertising and marketing materials is to identify all express and implied claims conveyed to consumers acting reasonably. Marketers must make sure that whatever they say expressly in advertising is accurate. Often, however, advertising conveys other claims beyond those expressly stated. Under FTC law, a marketer is equally responsible for the accuracy of claims suggested or reasonably implied in advertising.[17] Marketers can’t suggest benefits, safety, or other characteristics about their product indirectly that they couldn’t claim directly.
FTC law focuses not on the marketer’s intent, but on the consumer’s understanding. The determination of what claims are made in marketing is consumer-driven – in other words, what reasonable consumers understand the advertising or marketing materials to communicate about the product. When identifying the claims conveyed by an ad, marketers shouldn’t focus narrowly on individual phrases or statements, but rather should consider each ad as a whole, assessing the “net impression” conveyed by all elements of the ad, including the text, product name, and any charts, graphs, and other images.[18] When an ad lends itself to more than one reasonable interpretation, the advertiser is responsible for substantiating each interpretation.

[petroc] 03/5/2024 09:42

Thank you for posting that out of date and unrelated link, MDI. I see you've managed to push the share price up 8% already this morning!

[mdi] 03/5/2024 09:03

Haleon know all about the importance of ‘scientific substantiation’ ˜relative to placebo’.

No wonder Haleon demanded ‘performance obligations’

[petroc] 03/5/2024 08:21

Good to see buoyancy in the share price again, and MDI desperately trying to hold back the tide! He must wish he had some real ammunition instead of the tired old smoke and mirror deceptions, misdirection, obfuscations and total lies he regularly copy/pastes.

[wheeze] 03/5/2024 08:06

Glavey. Filtered.

[glavey] 03/5/2024 06:23

Erexon: 350 out of 449 (78%) reviewers recommend this product

Eroxon: 349 out of 464 (75%) reviewers don't recommend this product

[mdi] 02/5/2024 22:27

More akin to falling sales like cold soggy cakes when it fails to live up to the marketing hype. Eroxon revenue was £1.7m in April/May 2023 and then only £1.4m in the following 6 months. And more amazing to think they used the ‘least burdensome’ de novo medical device pathway to try substantiate implying its ‘clinically proven’ to work any better then any similar placebo hydroalcoholic gel would in the same lower class medical device tests.



˜Momentum grows to subject medical devices to medicines gold standard the placebo treatment’


And what are the ‘performance obligations’ which Futura has ‘tied up’ to with Haleon that still requires to be met?

‘upfront milestone payment which is to be recognised as a Contract Liability until satisfaction of the performance obligations’

If you read the full FDA letter to Futura dated June 9 2023 which the FDA have published. Perhaps that gives the ‘clarity’ and ‘perspective’ Haleon eluded to on the so called tie up with Futura.

Med3000 is still unable to support its efficacy claims with evidence from any double-blind, randomized, placebo-controlled clinical trial to substantiate any efficacy beyond just using any similar non medicated placebo hydroalcoholic gel.




Dear Ken James:

Page 3

Please be advised that FDA's decision to grant this De Novo request does not mean that FDA has made a determination that your device complies with other requirements of the FD&C Act or any Federal statutes and regulations administered by other Federal agencies



‘The FTC and the Food and Drug Administration (FDA) share jurisdiction over the marketing of dietary supplements, foods, drugs, devices, and other health-related products’



Meeting New Federal Guidelines And Retailer Requirements

In March 2023, federal regulators began investigating social media platforms for their potential role in advertising misleading products, including ones with fraudulent health claims. Then, in April 2023, federal regulators sent warning letters to 670 wellness companies related to health claims without proof.

[j777j] 02/5/2024 20:04

Amazing to realise Futura-Medical has tied up with Haleon one of the largest consumer healthcare cos on the planet.

[j777j] 02/5/2024 19:02

Strong sales in the rest of the first quarter, resulted in Eroxon® ranking third on Navamedic's most sold products in the Consumer Health segment. Eroxon® will be launched in Sweden in May, and in Finland later this year," said Kathrine Gamborg, CEO of Navamedic ASA.Selling like hotcakesUsa news coming soon

[broomrigg] 02/5/2024 17:49

Good news from Norway and Sweden etc.

[petroc] 02/5/2024 16:11

Hey, that's a good sign! After two weeks of silence, the lying MDI has returned to bash the stock some more! That can only mean he's worried that he's about to be outed as the worst stock basher in history - he's already proved he's the worst FUM investor ever!

[mdi] 02/5/2024 14:50

Similar to the ‘successful’ UK and Belgium launch?

Eroxon revenue was £1.7m in April/May 2023 and then only £1.4m in the following 6 months



Wellness Investors: Beware The Placebo Trap

Whats the problem with placebos? Placebo effects tend to wear off, and when they do, your customers will drop off. This forces tremendous spending on acquisition since it can cost five times as much to acquire new customers than keep current ones.

Since repeat customers generate more than half of the revenue for a majority of businesses, pretty packaging of a placebo will likely struggle to sustain sales. Perhaps the boom and bust commonly seen with wellness brands isn’t due to the hype cycle, but rather the placebo cycle.

[j777j] 02/5/2024 14:18

"The successful launch in Norway of Eroxon® in February was an important and significant event. After only two weeks in the market, this clinically proven local treatment of erectile dysfunction was the bestseller at an online pharmacy. Strong sales in the rest of the first quarter, resulted in Eroxon® ranking third on Navamedic's most sold products in the Consumer Health segment. Eroxon® will be launched in Sweden in May, and in Finland later this year," said Kathrine Gamborg, CEO of Navamedic ASA.

[blackhorse23] 29/4/2024 16:18

AlliancePharma [APH] has an impressive record of long-term growth & creating sustainable value for our shareholders & stakeholders-DIVIDEND +5% -PORTFOLIO BROADENED THROUGH ACQUISITION

[broomrigg] 19/4/2024 19:45

A good read......